Data / Medical devices / United States / D.T. Davis Enterprises Ltd.
D.T. Davis Enterprises Ltd.: FDA-registered device maker in Allentown, PA, United States, 2 510(k) clearances
D.T. Davis Enterprises Ltd. is registered with the FDA (registration 2531468) in Allentown, PA, United States. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 3, 2012. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2531468
- FEI number
- 3001600982
- Address
- 4482 Innovation Way, Allentown, PA, United States, 18109
- Owner or operator
- D.T. DAVIS ENTERPRISES LTD. T/A HoverTech International (9033042)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 12, 1998
- Registered through
- 2026
- Brand names listed
- AirWedge, Disposable Sheet, FPW Foam Positioning Wedge, HoverCover Fitted, HoverCover Slide, HoverCover Three-QTR, HoverJack, HoverMatt PROS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bedding, Disposable, Medical | KME | 1 | Specification developer | accessdata.fda.gov |
| Device, Patient Transfer, Powered | FRZ | 2 | Specification developer | accessdata.fda.gov |
| Device, Transfer, Patient, Manual | FMR | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Lift, Patient, Ac-Powered | FNG | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Lift, Patient, Non-Ac-Powered | FSA | 1 | Specification developer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 3, 2012 | K121287 | HT-WEDGE | FNG | Substantially Equivalent | D.T. Davis Enterprises Ltd. T/A Hovertech Int'L | accessdata.fda.gov |
| August 12, 2004 | K041503 | HOVERJACK AIR PATIENT LIFT DEVICE | FNG | Substantially Equivalent | D.T. Davis Enterprises , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 13, 2005 | 33722 | Not yet classified | Terminated | HoverMatt Patient Transfer Solution/Air Transfer Mattress | Instructions for use are not adhering to the product | accessdata.fda.gov |
Compare with other makers
- All makers of Lift, Patient, Ac-Powered
- All makers of Bedding, Disposable, Medical
- All makers of Protector, Skin Pressure
- All makers of Device, Patient Transfer, Powered
- All makers of Device, Transfer, Patient, Manual
- All makers of Lift, Patient, Non-Ac-Powered
Updated October 3, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.